PT - JOURNAL ARTICLE AU - Zuccarello, Daniel J. AU - Murphy, Michael P. AU - Meyer, Richard F. AU - Winslow, Paul A. TI - A Comprehensive Approach for the Determination of Extractable and Leachable Metals in Pharmaceutical Products by Inductively-Coupled Plasma DP - 2009 Jul 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 339--352 VI - 63 IP - 4 4099 - http://journal.pda.org/content/63/4/339.short 4100 - http://journal.pda.org/content/63/4/339.full SO - PDA J Pharm Sci Technol2009 Jul 01; 63 AB - A comprehensive digestive approach for determining the extractable and leachable metals in pharmaceutical products by inductively-coupled plasma is investigated. This study examines several acid digestion strategies for packaging materials, containers, and formulated products for complete trace metals analysis. Packaging materials, a food product, and a simulated drug product are evaluated for leachable metals by stressing the materials under accelerated stability conditions. Trace metal profiles of 64 elements for these materials are reported.